DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension

DORADO-EX - A Dose-Blinded, Long-Term Safety Extension Study of Fixed Doses of Darusentan in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Antihypertensive Drugs, Including a Diuretic (Protocol DAR-311-E)

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00353574

Acronym

Darusentan

Enrollment

282

Registered

2006-07-18

Start date

2006-09-30

Completion date

2010-04-30

Last updated

2014-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Resistant Hypertension

Brief summary

This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the United States (U.S.) Food and Drug Administration (FDA) for use in the U.S., which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan in subjects with resistant systolic hypertension despite treatment with full doses of three or more antihypertensive medications, including a diuretic.

Interventions

DRUGDarusentan

Darusentan capsules administered orally once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Subjects who have completed the Treatment Period of clinical trial DAR-311 * Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic

Exclusion criteria

* Subjects who discontinued treatment with study drug prior to the end of the Treatment Period of DAR-311 due to a study drug-related adverse event (AE) * Treatment with another endothelin receptor antagonist within 6 months of study entry

Design outcomes

Primary

Measure	Time frame
Change in trough sitting systolic and diastolic blood pressure	Baseline to Week 14

Secondary

Measure	Time frame
Change in mean 24-hour systolic and diastolic ambulatory blood pressures.	Baseline to Week 14
Percentage of subjects who reach systolic blood pressure goal	Week 14
Change in estimated glomerular filtration rate (eGFR)	Baseline to Week 14

Countries

Argentina, Brazil, Canada, Denmark, France, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026